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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceABBOTT REALTIME HCV GENOTYPE II
Generic NameAssay, genotyping, hepatitis c virus
Regulation Number866.3170
ApplicantABBOTT MOLECULAR
1300 EAST TOUHY AVENUE
DES PLAINES, IL 60018
PMA NumberP120012
Supplement NumberS009
Date Received07/29/2015
Decision Date10/09/2015
Reclassified Date 12/22/2021
Product Code OBF 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR TWO CHANGES TO THE APPLICATION SPECIFICATION FILES TO EXTEND THE CHILLER DELAY TIMER AND CHANGE THE CONDUCTIVITY SETTING FOR THE DETECTION OF RNA WASH2 LIQUID.
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